Diagnoses Associated With Persistent Elevation of Creatine Kinase

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT04838509
Collaborator
(none)
148
1
1.8
83.4

Study Details

Study Description

Brief Summary

Serum creatinine kinase (CK) level varies with age, gender, race and physical activity. For these reasons there is no normal serum CK level. Many pathological situations cause hyperCKemia, such as neuromuscular disorders (muscular dystrophy, inflammatory myositis, mitochondrial myopathy) and multiple systemic causes. The diagnostic approach to pauci or asymtomatic hyperCKemia can therefore be difficult and lead to multiple, and sometimes invasive tests, such as muscle biopsy. This study aims to describe the diagnoses associated with persistent elevation of serum creatine kinase and to precise the role of the muscule biopsy.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational
Actual Enrollment :
148 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Diagnoses Associated With Persistent Elevation of Creatine Kinase
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Jun 24, 2021
Actual Study Completion Date :
Jun 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients with elevated creatine kinase

Other: no intervention
retrospective descriptive without intervention

Outcome Measures

Primary Outcome Measures

  1. Diagnosis [at the end of all investigations, an average of 12 months]

    The final diagnosis, as written in the medical record at the end of the investigations in the ward of internal medicin, responsible for the elevation of creatine kinase between: inflammatory myositis, mitochondrial myopathy, muscular dystrophy, non neuromuscular pathology

Secondary Outcome Measures

  1. Muscle biopsy [at the end of all investigations, an average of 12 months]

    Among the patients who underwent a muscle biopsy, number of anormal biopsies that contributed to make the final diagnosis responsible of the elevation of creatine kinase

  2. Clinical presentation [at the end of all investigations, an average of 12 months]

    association between the initial clinical presentation and the final diagnosis

  3. Paraclinical presentation [at the end of all investigations, an average of 12 months]

    association between the initial paraclinical presentation and the final diagnosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients hospitalised in a ward of internal medicin

  • having a persistent elevation of serum creatine kinase >3 times the upper normal laboratory value, repeated for 2 times

Exclusion Criteria:
  • known neuro-muscular disease causing elevation of creatine kinase

  • evident post-traumatic cause responsible for the elevation of creatine kinase

  • incomplete medical records

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Nancy Nancy France 54000

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lev VOLKOV, Dr, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT04838509
Other Study ID Numbers:
  • 2021PI034
First Posted:
Apr 9, 2021
Last Update Posted:
Jun 25, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lev VOLKOV, Dr, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 25, 2021